UPCC 06625 A Phase 3 Randomized Study of Intralesional Cemiplimab versus Primary Surgery in Participants with Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)
Investigating Directly Administered Investigational Medication versus Surgery for Early Stage Skin Cancer
Brief description of study
This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC).
The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810).
The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks.
The study is also looking at several other research questions, including:
- What side effects may happen from taking the study drug
- To see effect of cemiplimab on the tumor
- How much study drug is in the blood at different times
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma
-
Age: 18 years or above
-
Gender: All
Key Inclusion Criteria
- Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol
- Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Key Exclusion Criteria
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)
- Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.
- Prior treatment with other systemic immune modulating agent as defined in the protocol
- M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years
- Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded.
- Patients with a history of solid organ transplant
- Has received a Coronavirus induced disease of 2019 (COVID-19) vaccination (initial series and booster) within 1 week of planned start of study medication
Note: Other protocol defined Inclusion/Exclusion criteria apply.
This study investigates the use of an investigational medication in comparison to primary surgery for individuals with early stage Cutaneous Squamous Cell Carcinoma (CSCC). This study aims to understand how the investigational medication affects the tumor and the body, as well as the potential side effects that may occur.
Participants in the study will receive the investigational medication weekly for 12 weeks. The study will monitor the amount of the medication in the blood at different times to evaluate its effects. The study also aims to determine the safety and tolerability of the investigational medication, which refers to how well participants' bodies handle the treatment.
- Who can participate: Participants must be adults with recurrent resectable CSCC or BCC, having measurable disease in the index lesion of 1-2 cm, and an ECOG status of 0 or 1. Exclusions include recent autoimmune disease, prior PD-1/PD-L1 treatment, and recent COVID-19 vaccination.
- Study details: Participants will receive the investigational medication weekly for 12 weeks, with assessments of bodily reactions and side effects. Medication levels in the blood will be measured at various times.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
Contact Abramson Cancer Center NavigatorPlease choose between Voice or SMS based delivery of verification code
or